Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. We have four approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and have several ongoing clinical and research programs in CF. Beyond CF, we have a robust pipeline of investigational medicines in other serious diseases where we have deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney diseases.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, we have research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes.
In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
Vertex/VCGT is searching for an experienced Medical Director to serve as the Medical Lead and primary Medical Monitor for Type 1 Diabetes clinical trials. The Medical Director will assist with the clinical development strategy, work with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution, and act as liaison between clinical development and other internal groups at Vertex/VCGT.
- Prepare and execute the clinical development plans, in conjunction with other relevant functional areas,
- Serve as medical monitor for the assigned trials, assessing issues related to protocol conduct and subject safety.
- Participate in the development of study protocols, statistical analysis plans, investigator's brochures, and other key study documents in conjunction with other line functions and with minimal guidance
- Serve on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution, and data analysis
- Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of INDs and CTAs, safety reports, responses to regulatory authorities, clinical study reports, and other documents as appropriate
- Interface with regulatory authorities as appropriate
- Act as liaison between clinical development and other internal groups at Vertex/VCGT for assigned studies
- Provide medical and development leadership for cross-functional teams, including for external innovation/business development
- Represent Vertex/VCGT to outside medical personal in the development of clinical protocols and study conduct
- Represent Vertex/VCGT to outside stakeholders, including patient advocacy groups
- MD, or DO
- Minimum of 2 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and clinical development programs
- Board certification/eligibility in endocrinology, or another relevant specialty area, is highly desired
- Clinical development and/or clinical experience in rare disease, cell therapy, transplantation, medical devices
- Global clinical research experience and experience interacting with regulatory authorities is a plus
Ability to work collaboratively in a fast-paced, team-based matrix environment
Ability to work independently to resolve challengesExcellent oral and written communication skills